Clinical trial · Observational
Intestinal Microbiome, Oral Microbiome, and Whole Blood Transcriptome Analyses in Gastrointestinal Malignancies
An Evaluation of the Intestinal Microbiome, Oral Microbiome, and Whole Blood Transcriptome Analyses in Gastrointestinal Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this prospective observational study is to characterize the gut and oral microbiome as well as the whole blood transcriptome in gastrointestinal cancer patients and correlate these findings with cancer type, treatment efficacy and toxicity. Participants will be recruited from existing clinical sites only, no additional clinical sites are needed.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Cancer | — | UNRESOLVED | — |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Gastrointestinal Malignancies (pancreatic, colorectal, gastroesophageal, and hepatobiliary)
- description
- Individuals with a gastrointestinal malignancy including pancreatic, colorectal, gastroesophageal, or hepatobiliary malignancies.
Primary outcomes (2)
- measure
- Characterization of the microbiome in Gastrointestinal Malignancy
- timeFrame
- 3 years
- description
- Determining the number of species present in the sample.
- measure
- Levels of gene expression of the identified species in Gastrointestinal Malignancy
- timeFrame
- 3 years
- description
- Determining the levels of gene expression in the species found.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic diagnosis of gastrointestinal malignancy including pancreatic, esophageal, gastric, colon, rectal, hepatocellular, or biliary carcinoma. * Subjects must have a) newly diagnosed recurrent or metastatic disease b) progressive disease on second or later line therapies, or c) locally advanced inoperable disease receiving palliative therapy. * Age \> 18 years. * Ability to understand and willing to sign a written informed consent document. Exclusion Criteria: * Subjects with gastrointestinal malignancy already receiving treatment including chemotherapy, immunotherapy, radiation therapy or investigational agents for treatment of a) newly diagnosed recurrent or metastatic disease b) progressive disease on second or later line therapies, or c) locally advanced disease. * Subjects with gastrointestinal malignancy who will not be receiving cancer directed therapy including chemotherapy, immunotherapy, radiation therapy or investigational agents. * Subjects with active infectious gastroenteritis.
References
Publications (0)
Data not yet available